Full Press Release Details
U.S. FDA Approves IceCure's Post-Marketing
"ChoICE" Study for ProSense Cryoablation in the Local Treatment of Low-Risk Breast Cancer
IceCure is engaged with leading medical institutions
throughout the U.S. looking to participate in the post-market study with the FDA-cleared ProSense
Clinical study sites may offer ProSense
cryoablation to additional patients not enrolled in the study, supporting its potential broader commercial adoption
Post-market study will be conducted using cryoprobes
sold exclusively by IceCure and facilities will be able to use CPT Category III reimbursement code
CAESAREA, Israel, March 11, 2026 -
IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of
minimally-invasive cryoablation technology that destroys tumors by freezing as an option to surgical tumor removal, today announced that
the U.S. Food and Drug Administration ("FDA") has approved the study design for the "ChoICE Trial Post-Market Study,"
the Company's post-marketing study for ProSense in the treatment of low-risk breast cancer (the "Study"). Patient
enrollment is expected to commence in the second half of 2026, with at least 80 patients expected to be enrolled in the first year of
The FDA previously granted marketing authorization
in October 2025 for ProSense for the treatment of patients aged 70 years and older with biologically low-risk tumors 1.5 cm in
size who are treated with adjuvant endocrine therapy. In connection with its grant of marketing authorization, the FDA requested that
IceCure conduct a post-market surveillance study to generate additional real-world data regarding the use of ProSense in this indication.
The Study is expected to enroll and treat approximately
400 patients across 30 clinical sites in the U.S. within 36 months. IceCure has already received interest and engagement from leading
medical institutions across the country seeking to participate in the Study. Under the approved study design, participating sites will
treat enrolled patients while also serving as active commercial sites, providing cryoablation to patients outside of the study, thereby
supporting the Company's commercial expansion. The Study will be conducted using cryoprobes sold exclusively by IceCure and facilities
will be able to use an established CPT Category III reimbursement code.
"We believe the combination of FDA marketing
authorization, this FDA-approved post-market study with 30 clinical sites across the country, supportive American Society of Breast Surgeons
("ASBrS") guidelines, an established reimbursement code, and strong physician engagement positions us to meaningfully expand
access to ProSense as a minimally invasive treatment option for eligible breast cancer patients across the U.S.," stated Eyal
Shamir, Chief Executive Officer of IceCure. "We are also very pleased to work with two leading thought leaders in breast cancer
treatment, Dr. Robert Ward and Dr. Nathalie Johnson, who will be Co-Principal Investigators of the Study."
Robert C. Ward, M.D., is a specialist in women's
imaging and breast tumor cryoablation. Dr. Ward is an experienced clinical investigator who has authored and co-authored several publications
on breast cancer cryoablation and is a skilled ProSense user. He is Assistant Professor of Diagnostic Imaging and Program Director
for the Breast Imaging Fellowship at the Warren Alpert Medical School at Brown University, and Associate Chief of Diagnostic Imaging at
Women & Infants Hospital of Rhode Island.
Nathalie McDowell Johnson, M.D., FACS, is Senior
Medical Director of the Legacy Health Systems Cancer Institute and Legacy Breast Health Centers in Portland, Oregon. Dr. Johnson is the
former President of the ASBrS and is an avid supporter of expanding minimally invasive treatment options for breast cancer patients.
Study procedures are eligible for reimbursement
under the established Centers for Medicaid and Medicare Services CPT Category III code, which provides approximately $4,000 for the facility
fee alone. IceCure believes the existing reimbursement framework may support reimbursement claims for study procedures, and that additional
reimbursement pathways may develop over time, particularly in light of the recent FDA marketing authorization and inclusion of cryoablation
for breast cancer in the updated ASBrS resource guide.
The ProSense Cryoablation System is the first
and only medical device to receive FDA marketing authorization for the local treatment of low-risk breast cancer with adjuvant endocrine
therapy for women aged 70 and above, including patients who are not suitable for surgical alternatives for breast cancer treatment. A
full list of benefits and risks can be found on the Company's website.
ProSense is a minimally invasive cryosurgical
tool that provides the option to destroy tumors by freezing them. The system uniquely harnesses the power of liquid nitrogen to create
large lethal zones for maximum efficacy in tumor destruction in benign and cancerous lesions, including in the breast, kidney, lung, and
ProSense enhances patient and provider value
by accelerating recovery, reducing pain, surgical risks, and complications. With its easy, transportable design and liquid nitrogen utilization,
ProSense opens the door to fast and convenient office-based procedures for breast tumors.
About IceCure Medical
IceCure Medical (Nasdaq: ICCM) develops and markets
advanced liquid-nitrogen-based cryoablation therapy systems for the destruction of tumors (benign and cancerous) by freezing, with the
primary focus areas being breast, kidney, bone and lung cancer. Its minimally invasive technology is a safe and effective option to surgical
tumor removal that is easily performed in a relatively short procedure. The Company's flagship ProSense system is marketed and sold
worldwide for the indications cleared and approved to date including in the U.S., Europe and Asia.
Forward Looking Statement
This press release contains
forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act
of 1995 and other Federal securities laws. Words such as "expects," "anticipates," "intends," "plans,"
"believes," "seeks," "estimates" and similar expressions or variations of such words are intended to identify
forward-looking statements. For example, IceCure is using forward looking statements in this press release when it discusses:
the expected commencement of patient enrollment in the Study in the second half of 2026; the anticipated enrollment of at least 80 patients
in the first year of the study and approximately 400 patients across 30 clinical sites within 36 months; the belief that the combination
of FDA marketing authorization, the post-market study, ASBrS guidelines, established reimbursement codes, and physician engagement may
support broader access to ProSense as a minimally invasive treatment option for eligible breast cancer patients; the expectation
that participating clinical sites will serve as active commercial sites supporting the Company's commercial expansion; the belief
that the existing CPT Category III reimbursement framework may support reimbursement claims for study procedures; and the expectation
that additional reimbursement pathways may develop over time in light of the FDA marketing authorization and updated ASBrS resource guide.
Historical results of scientific research and clinical and preclinical trials do not guarantee that the conclusions of future research
or trials will suggest identical or even similar conclusions. Important factors that could cause actual results, developments and business
decisions to differ materially from those anticipated in these forward-looking statements include, among others: the Company's planned
level of revenues and capital expenditures; the Company's available cash and its ability to obtain additional funding; the Company's ability
to market and sell its products; legal and regulatory developments in the United States and other countries; the Company's ability
to maintain its relationships with suppliers, distributors and other partners; the Company's ability to maintain or protect the validity
of its patents and other intellectual property; the Company's ability to expose and educate medical professionals about its products;
political, economic and military instability in the Middle East, specifically in Israel; as well as those factors set forth
in the Risk Factors section of the Company's Annual Report on Form 20-F for the year ended December 31, 2024 filed with the
SEC on March 27, 2025, and other documents filed with or furnished to the SEC which are available on the SEC's website, www.sec.gov.
The Company undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required